A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants
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ClinicalTrials.gov Identifier: NCT01062477 |
Recruitment Status :
Completed
First Posted : February 4, 2010
Last Update Posted : December 13, 2011
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The purpose of this study is to assess the immunogenicity and safety of ACTACEL combined vaccine in support of registration of this product in China
Primary Objectives:
- To demonstrate that ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age is not inferior, in terms of seroprotection, to Wuhan's Diphtheria, Tetanus, acellular Pertussis (DTaP) and Haemophilus influenzae type b (Act-HIB) vaccine given concomitantly, for diphtheria, tetanus, and Polyribosyl Ribitol Phosphate (PRP) antigens, one month after the three-dose primary vaccination.
- To demonstrate the superiority, in terms of seroconversion, of ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age for Pertussis Toxoid (PT), Fimbriae types 2 and 3 (FIM2) and (FIM3) pertussis antigens, compared with Wuhan's DTaP and Act-HIB vaccines given concomitantly, one month after the three-dose primary vaccination.
Secondary Objectives:
- To describe the safety after administration of the study vaccines.
- To describe in each group the immunogenicity of the study vaccines one month after the primary vaccination and before and one month after the booster vaccination.
Condition or disease | Intervention/treatment | Phase |
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Diphtheria Tetanus Pertussis Haemophilus Influenzae Type B | Biological: DTaP//PRP-T Combined Vaccine Biological: DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1056 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Safety and Immunogenicity of the Sanofi Pasteur's DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Hib Conjugate (Act-HIB) Monovalent Vaccine as a Three-dose Primary and Booster Vaccination in Healthy Infants in China |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
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Experimental: Study Group 1
Participants will receive ACTACEL vaccine at 2, 3, and 4 months of age.
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Biological: DTaP//PRP-T Combined Vaccine
0.5 mL, Intramuscular
Other Name: ACTACEL |
Experimental: Study Group 2
Participants will receive ACTACEL vaccine at 3, 4, and 5 months of age.
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Biological: DTaP//PRP-T Combined Vaccine
0.5 mL, Intramuscular
Other Name: ACTACEL |
Active Comparator: Study Group 3
Participants will receive Wuhan DTaP and Act-HIB vaccines concomitantly at 3, 4 and 5 months of age.
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Biological: DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine
0.5 mL, Intramuscular (each vaccine)
Other Name: Act-HIB™ |
- Immunogenicity: To provide information concerning the immunogenicity of ACTACEL vaccine after primary and booster vaccination. [ Time Frame: One month post-vaccination ]
- Safety: To provide information concerning the safety after primary and booster administration of ACTACEL vaccine. [ Time Frame: 0-7 days post-vaccination and entire study duration ]

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Ages Eligible for Study: | 60 Days to 89 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
- Aged 2 months on the day of inclusion
- Born at full term pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg
- Informed consent form signed by the parent(s) or legal representative
- Participant and parent/legal representative able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria :
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or long-term systemic corticosteroids therapy
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
- Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
- Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except oral poliovirus (OPV), bacillus Calmette-Guérin (BCG), and Hepatitis B vaccines which cannot be given within 8 days before or after any study vaccination)
- History of seizures
- Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B (HB) surface antigen or Hepatitis C seropositivity
- History of diphtheria, tetanus, pertussis or Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically)
- Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae type b disease with either the trial vaccine or another vaccine
- Participant at high risk for diphtheria, tetanus, pertussis or Haemophilus influenzae type b infection during the trial
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
- History of contraindication to vaccination with pertussis-containing vaccine
- Febrile illness (axillary temperature ≥37.1°C) or moderate or severe acute illness/infection on the day of inclusion, according to Investigator judgment
Temporary contraindications that must be resolved before vaccination:
- Acute febrile illness within the 72 hours preceding the vaccination, or temperature ≥37.1°C present at this visit
- Any vaccination in the 4 weeks preceding the vaccination (except OPV, BCG, and hepatitis B vaccines which cannot be given within 8 days before or after any study vaccination)
- Systemic corticosteroids therapy (prednisone or equivalent) for more than 2 consecutive weeks within the past 3 months

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062477
China, Guangxi | |
LingChuan County, Guilin City, Guangxi, China, 541200 | |
Lipu County, Guilin City, Guangxi, China, 546600 |
Study Director: | Medical Director | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT01062477 |
Other Study ID Numbers: |
C5A06 UTN: U1111-1112-2509 ( Other Identifier: WHO ) |
First Posted: | February 4, 2010 Key Record Dates |
Last Update Posted: | December 13, 2011 |
Last Verified: | December 2011 |
Diphtheria Tetanus Pertussis Haemophilus Influenzae Type B |
Whooping Cough Tetanus Diphtheria Respiratory Tract Infections Infections Respiratory Tract Diseases Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections |
Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Corynebacterium Infections Actinomycetales Infections Vaccines Immunologic Factors Physiological Effects of Drugs |